FDA.reportPublic FDA data

Equate Lidocaine Cool and Heat Patch 5 ct

Manufacturer
Walmart Stores Inc
Effective date
2025-12-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:28:55

Label at a glance#

ProductEquate Lidocaine Cool and Heat
Active ingredientMENTHOL, LIDOCAINE
Label structure8 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

Adults and children 12 years of age and over: Clean and the dry affected area. Carefully remove backing from the patch starting at a corner. Apply the sticky side of patch to the affected area. Use one patch for up to 12 hours. Discard patch after a single use. Children under 12 years old of age: consult a physician.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.0%
Menthol 1.0%

OTC - PURPOSE SECTION

Topical Anesthetic
Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

- Warnings

WARNINGS SECTION



For external use only.

OTC - WHEN USING SECTION

Use only as directed
Read and follow all directions and warnings on this carton
Do not allow contact with the eyes
Do not use at the same time as other topical analgesics
Do not bandage tightly or apply local heat (such as heating pads) to the area of use
Do not microwave
Dispose of the used patch in a manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

OTC - DO NOT USE SECTION

More than one patch on your body at a time.
On cut, irritated or swollen skin
On puncture wounds
For more than one week without consulting a doctor
If you are allergic to any active or inactive ingredients
If pouch is damaged or opened

Stop and ask a doctor

OTC - ASK DOCTOR SECTION

Condition worsens
Redness is present
Irritation develops
Symptoms persist for more than 7 days or clear up and occur again within a few days
You experience signs of skin injury, such as pain, swelling or blistering where the product was applied

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center ( 1800-222-1222) right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: Clean and the dry affected area. Carefully remove backing from the patch starting at a corner. Apply the sticky side of patch to the affected area. Use one patch for up to 12 hours. Discard patch after a single use. Children under 12 years old of age: consult a physician.

OTHER SAFETY INFORMATION

Store in a clean, dry place outside of direct sunlight. Protect for excessive moisture.

INACTIVE INGREDIENT SECTION

Aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Equate Lidocaine + Menthol Pain Relief Patch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN4
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD4
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-038-05Equate Lidocaine Cool and Heat5 in 1 BOXPATCH54
79903-038-05Equate Lidocaine Cool and Heat6 g in 1 POUCHPATCH64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79903-038-05EA - Each79903-038e6b13827-c737-40aa-a139-dfbd73baeaa412025-07-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79903-03879903-038-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
KAOLIN24H4NWX5COIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
MENTHOLL7T10EIP3AACTIB
LIDOCAINE98PI200987ACTIB
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Lidocaine Cool and HeatLIDOCAINE 4% PLUS MENTHOL 1%Walmart Stores Incb86769c3-a0b4-c481-e053-2a95a90af38b2025-12-27WarningsExact identifier
ndc (package): 79903-038-05
ndc (product): 79903-038
ndc11 (package): 79903003805
spl id: 46f6b370-84c5-11bb-e063-6394a90a706b
spl set id: b86769c3-a0b4-c481-e053-2a95a90af38b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.